SIST EN ISO 11663:2016
(Main)Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
This International Standard specifies minimum quality requirements for dialysis fluids used in
haemodialysis and related therapies.
This International Standard includes dialysis fluids used for haemodialysis and haemodiafiltration,
including substitution fluid for haemodiafiltration and haemofiltration.
This International Standard does not address the requirements for the water and concentrates used
to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other
International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of
dialysis fluid, systems for continuous renal replacement therapy that use prepackaged solutions, and
systems and solutions for peritoneal dialysis are excluded from this International Standard.
Qualität von Konzentraten für die Hämodialyse und verwandte Therapien (ISO 11663:2014)
Qualité des fluides de dialyse pour hémodialyse et thérapies apparentées (ISO 11663:2014)
ISO 11663:2014 spécifie des exigences de qualité minimales pour les fluides de dialyse dans le cadre d'hémodialyses et de thérapies apparentées.
Elle inclut les fluides de dialyse utilisés pour l'hémodialyse et l'hémofiltration, notamment le fluide de substitution pour hémodiafiltration et hémofiltration.
Elle n'aborde pas les exigences relatives à l'eau et aux concentrés utilisés pour préparer le fluide de dialyse ou l'équipement utilisé lors de sa préparation. Ces domaines sont traités par d'autres Normes internationales.
Les systèmes de régénération des fluides de dialyse à base de sorbant qui régénèrent et remettent en circulation de petits volumes de fluide de dialyse, les systèmes pour traitements continus de suppléance rénale qui utilisent des solutions préemballées et les systèmes et solutions pour dialyse péritonéale sont exclus de la présente Norme internationale.
Kakovost tekočin za hemodializo in podobne terapije (ISO 11663:2014)
Ta mednarodni standard določa zahteve glede minimalne kakovosti za tekočine za hemodializo in podobne terapije. Ta mednarodni standard vključuje tekočine za hemodializo in hemodiafiltracijo, vključno z nadomestno tekočino za hemodiafiltracijo in hemofiltracijo. Ta mednarodni standard ne obravnava zahtev za vodo in koncentrate, ki se uporabljajo za pripravo dializne tekočine, ali za opremo, ki se uporablja za njeno pripravo. Te vidike obravnavajo drugi mednarodni standardi. Sistemi za regeneracijo dializne tekočine na osnovi sorbenta za regeneracijo in recirkulacijo majhnih količin dializne tekočine, sistemi za neprekinjeno nadomestno ledvično zdravljenje, pri katerih se uporabljajo predpakirane raztopine, ter sistemi in raztopine za peritonealno dializo so izključeni iz tega mednarodnega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11663:2016
01-januar-2016
.DNRYRVWWHNRþLQ]DKHPRGLDOL]RLQSRGREQHWHUDSLMH ,62
Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
Qualität von Konzentraten für die Hämodialyse und verwandte Therapien (ISO
11663:2014)
Qualité des fluides de dialyse pour hémodialyse et thérapies apparentées (ISO
11663:2014)
Ta slovenski standard je istoveten z: EN ISO 11663:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 11663:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11663:2016
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SIST EN ISO 11663:2016
EN ISO 11663
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Quality of dialysis fluid for haemodialysis and related
therapies (ISO 11663:2014)
Qualité des fluides de dialyse pour hémodialyse et Qualität von Konzentraten für die Hämodialyse und
thérapies apparentées (ISO 11663:2014) verwandte Therapien (ISO 11663:2014)
This European Standard was approved by CEN on 10 October 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11663:2015 E
worldwide for CEN national Members.
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SIST EN ISO 11663:2016
EN ISO 11663:2015 (E)
Contents Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 5
2
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SIST EN ISO 11663:2016
EN ISO 11663:2015 (E)
Foreword
The text of ISO 11663:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for
surgery” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 11663:2015 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2016, and conflicting national standards shall be
withdrawn at the latest by May 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1 — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO or IEC
standard
1
ISO 13958 ISO 13958:2014
EN ISO 13958:2015
2
ISO 13959 ISO 13959:2014
EN ISO 13959:2015
1)
To be published
2)
To be published.
3
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SIST EN ISO 11663:2016
EN ISO 11663:2015 (E)
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11663:2014 has been approved by CEN as EN ISO 11663:2015 without any modification.
4
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SIST EN ISO 11663:2016
EN ISO 11663:2015 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption
of conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Essential Requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
4 7.2
3.13 7.3
4.1 8
1.3 13.6. (c)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
5
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SIST EN ISO 11663:2016
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SIST EN ISO 11663:2016
INTERNATIONAL ISO
STANDARD 11663
Second edition
2014-04-01
Quality of dialysis fluid for
haemodialysis and related therapies
Qualité des fluides de dialyse pour hémodialyse et thérapies
apparentées
Reference number
ISO 11663:2014(E)
©
ISO 2014
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SIST EN ISO 11663:2016
ISO 11663:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 11663:2016
ISO 11663:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 6
4.1 Microbiological contaminants in dialysis fluid . 6
4.2 Chemical contaminants in dialysis fluid . 7
5 Tests for compliance with microbiological requirements . 7
Annex A (informative) Rationale for the development and provisions of this
International Standard . 9
Annex B (informative) Reference tables from ISO 13959 .12
Bibliography .15
© ISO 2014 – All rights reserved iii
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SIST EN ISO 11663:2016
ISO 11663:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 11663:2009) which has been technically
revised.
iv © ISO 2014 – All rights reserved
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SIST EN ISO 11663:2016
ISO 11663:2014(E)
Introduction
Haemodialysis patients are directly exposed to large volumes of dialysis fluid, with the dialyser
membrane being the only barrier against transfer of hazardous contaminants from the dialysis fluid
to the patient. It has long been known that there could be hazardous contaminants in the water and
concentrates used to prepare the dialysis fluid. To minimize this hazard, ISO 13958 and ISO 13959 set
forth quality requirements for the water and concentrates used to prepare dialysis fluid. However, if the
dialysis fluid is not prepared carefully, it could contain unacceptable levels of contaminants even though
it is prepared from water and concentrates, meeting the requirements of ISO 13958 and ISO 13959.
Further, the dialysis fluid might be used as the starting material for the online preparation of fluids
intended for infusion into the patient, for example, in therapies such as online haemodiafiltration. For
these reasons, this International Standard for dialysis fluid quality was developed to complement the
existing International Standards for water and concentrates, ISO 13959 and ISO 13958, respectively.
Guidelines to aid the user in routinely meeting the requirements of this International Standard and
ISO 13959 can be found in ISO 23500.
Within these International Standards, measurement techniques current at the time of preparation have
been cited. Other standard methods can be used, provided that such methods have been appropriately
validated and compared to the cited methods.
This International Standard reflects the conscientious efforts of healthcare professionals, patients,
and medical device manufacturers to develop recommendations for the quality of dialysis fluid. This
International Standard is directed at the healthcare professionals involved in the management of dialysis
facilities and the routine care of patients treated in dialysis facilities, since they are responsible for the
final preparation of dialysis fluid. The recommendations contained in this International Standard are
not intended for regulatory application.
The requirements of this International Standard aim to help protect haemodialysis patients from adverse
effects arising from known chemical and microbiological contaminants that can be found in improperly
prepared dialysis fluid. However, the physician in charge of dialysis has the ultimate responsibility for
ensuring that the dialysis fluid is correctly formulated and meets the requirements of all applicable
quality standards.
The verbal forms used in this International Standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
International Standard,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this International Standard, and
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
The concepts incorporated in this International Standard should not be considered inflexible or static.
The recommendations presented here should be reviewed periodically in order to assimilate increased
understanding of the role of dialysis fluid purity in patient outcomes and technological developments.
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SIST EN ISO 11663:2016
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SIST EN ISO 11663:2016
INTERNATIONAL STANDARD ISO 11663:2014(E)
Quality of dialysis fluid for haemodialysis and related
therapies
1 Scope
This International Standard specifies minimum quality requirements for dialysis fluids used in
haemodialysis and related therapies.
This International Standard includes dialysis fluids used for haemodialysis and haemodiafiltration,
including substitution fluid for haemodiafiltration and haemofiltration.
This International Standard does not address the requirements for the water and concentrates used
to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other
International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of
dialysis fluid, systems for continuous renal replacement therapy that use prepackaged solutions, and
systems and solutions for peritoneal dialysis are excluded from this International Standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 13958, Concentrates for haemodialysis and related therapies
ISO 13959, Quality of water for haemodialysis and related therapies
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
acid concentrate
A-concentrate
acidified concentrated mixture of salts that, when diluted with dialysis water and bicarbonate
concentrate, yields dialysis fluid for use in dialysis
Note 1 to entry: The term “acid” refers to the small amount of acid (for example, acetic acid or citric acid) that is
included in the concentrate.
Note 2 to entry: Acid concentrate may contain glucose.
Note 3 to entry: Acid concentrate may be in the form of a liquid, a dry powder, other highly concentrated media,
or some combination of these forms.
3.2
action level
concentration of a contaminant at which steps should be taken to interrupt the trend toward higher,
unacceptable levels
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SIST EN ISO 11663:2016
ISO 11663:2014(E)
3.3
bicarbonate concentrate
B-concentrate
concentrated preparation of sodium bicarbonate that, when diluted with dialysis water and acid
concentrate, makes dialysis fluid used for dialysis
Note 1 to entry: Sodium bicarbonate is also known as sodium hydrogen carbonate.
Note 2 to entry: Some bicarbonate concentrates also contain sodium chloride.
Note 3 to entry: Bicarbonate concentrate can be in the form of a liquid or a dry powder.
Note 4 to entry: Dry sodium bicarbonate, without added sodium chloride, is also used in concentrate generators
to produce a concentrated solution of sodium bicarbonate used by the dialysis machine to make dialysis fluid.
3.4
central dialysis fluid delivery system
system that produces dialysis fluid from dialysis water and concentrate or powder at a central point and
distributes the dialysis fluid from the central point to individual dialysis machines
3.5
chlorine, combined
chlorine that is chemically combined, such as in chloramine compounds
Note 1 to entry: There is no direct test for measuring combined chlorine, but it may be measured indirectly by
measuring both total and free chlorine and calculating the difference.
3.6
chlorine, free
chlorine present in water as dissolved molecular chlorine (Cl), hypochlorous acid (HOCI), and
−
hypochlorite ion (OCl )
Note 1 to entry: The three forms of free chlorine exist in equilibrium.
3.7
chlorine, total
sum of free and combined chlorine
Note 1 to entry: Chlorine can exist in water as dissolved molecular chlorine, hypochlorous acid and/or hypochlorite
ion (free chlorine), or in chemically combined forms (combined chlorine). Where chloramine is used to disinfect
water supplies, chloramine is usually the principal component of combined chlorine.
3.8
colony-forming unit
CFU
measure of bacterial or fungal cell numbers that theoretically arise from a single cell when grown on
solid media
Note 1 to entry: Colonies can also form from groups of organisms when they occur in aggregates.
3.9
concentrate generator
system where the concentrate is delivered to the user as a powder in a container, suitable for attachment
to the dialysis machine with which it is intended to be used, and then the powder is converted into a
concentrated solution by the dialysis machine
Note 1 to entry: The solution produced by the concentrate generator is used by the dialysis machine to make the
final dialysis fluid delivered to the dialyser
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SIST EN ISO 11663:2016
ISO 11663:2014(E)
3.10
device
individual water purification unit, such as a softener, carbon bed, reverse osmosis unit, or deionizer
Note 1 to entry: This term is synonymous with the term “component” as used by the US Food and Drug
Administration (see Reference [48]).
3.11
dialysis fluid
dialysate
dialysis solution
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange
solutes with blood during haemodialysis
Note 1 to entry: The term “dialysis fluid” is used throughout this International Standard to mean the fluid made
from dialysis water and concentrates that is delivered to the dialyser by the dialysis fluid delivery system. Such
phrases as “dialysate” or “dialysis solution” are used in place of dialysis fluid in some countries; however, that
usage is discouraged to avoid confusion.
Note 2 to entry: The dialysis fluid entering the dialyser is referred to as “fresh dialysis fluid”, while the fluid
leaving the dialyser is referred to as “spent dialysis fluid”.
Note 3 to entry: Dialysis fluid does not include prepackaged parenteral fluids used in some renal replacement
therapies, such as haemodiafiltration and haemofiltration.
3.12
dialysis fluid delivery system
device that prepares dialysis fluid online from dialysis water and concentrates or that stores and
distributes premixed dialysis fluid; circulates the dialysis fluid through the dialyser; monitors the
dialysis fluid for temperature, conductivity (or equivalent), pressure, flow, and blood leaks; and, prevents
dialysis during disinfection or cleaning modes
Note 1 to entry: The term includes reservoirs, conduits, proportioning devices for the dialysis fluid, and monitors
and associated alarms and controls assembled as a system for the purposes listed above.
Note 2 to entry: The dialysis fluid delivery system might be an integral part of the single-patient dialysis machine
or a centralized preparation system which feeds multiple bedside monitoring systems.
Note 3 to entry: Dialysis fluid delivery systems are also known as proportioning systems and dialysis fluid supply
systems.
3.13
dialysis water
water that has been treated to meet the requirements of ISO 13959 and which is suitable for use in
haemodialysis applications, including the preparation of dialysis fluid, reprocessing of dialysers,
preparation of concentrates, and preparation of substitution fluid for online convective therapies
3.14
disinfection
destruction of pathogenic and other kinds of microorganisms by thermal or chemical means
Note 1 to entry: Disinfection is a less lethal process than sterilization, because it destroys most recognized
pathogenic microorganisms but does not necessarily destroy all microbial forms.
3.15
endotoxin
major component of the outer cell wall of gram-negative bacteria
Note 1 to entry: Endotoxins are lipopolysaccharides, which consist of a polysaccharide chain covalently bound
to lipid A. Endotoxins can acutely activate both humoral and cellular host defences, leading to a syndrome
characterized by fever, shaking, chills, hypotension, multiple organ failure, and even death if allowed to enter the
circulation in a sufficient dose. [see also pyrogen (3.25)].
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SIST EN ISO 11663:2016
ISO 11663:2014(E)
3.16
endotoxin units
EU
units assayed by the Limulus amoebocyte lysate (LAL) test when testing for endotoxins
Note 1 to entry: Because activity of endotoxins depends on the bacteria from which they are derived, their activity
is referred to a standard endotoxin.
Note 2 to entry: In some countries, endotoxin concentrations are expressed in international units (IU). Since the
harmonization of endotoxin assays, EU and IU are equivalent.
3.17
haemodiafiltration
form of renal replacement therapy in which waste solutes are removed from blood by a combination of
diffusion and convection through a high-flux membrane
Note 1 to entry: Diffusive solute removal is achieved using a dialysis fluid stream as in haemodialysis. Convective
solute removal is achieved by adding ultrafiltration in excess of that needed to obtain the desired weight loss; fluid
balance is maintained by infusing a replacement solution into the blood either before the dialyser (predilution
haemodiafiltration), after the dialyser (postdilution haemodiafiltration), or a combination of the two (mixed
dilution haemodiafiltration).
3.18
haemodialysis
form of renal replacement therapy in which waste solutes are removed primarily by diffusion from
blood flowing on one side of a membrane into dialysis fluid flowing on the other side
Note 1 to entry: Fluid removal that is sufficient to obtain the desired weight loss is achieved by establishing a
hydrostatic pressure gradient across the membrane. This fluid removal provides some additional waste solute
removal, particularly for solutes with higher molecular weight.
3.19
haemofiltration
form of renal replacement therapy in which waste solutes are removed from blood by convection
Note 1 to entry: Convective transport is achieved by ultrafiltration through a high-flux membrane. Fluid balance
is maintained by infusing a replacement solution into the blood either before the haemofilter (predilution
haemofiltration), after the haemofilter (postdilution haemofiltration), or a combination of the two (mixed dilution
haemofiltration).
Note 2 to entry: There is no dialysis fluid stream in haemofiltration.
3.20
Limulus amoebocyte lysate test
LAL test
assay used to detect endotoxin
Note 1 to entry: The detection method uses the chemical response of an extract from blood cells of a horseshoe
crab (Limulus polyphemus) to endotoxins.
Note 2 to entry: Amebocyte lysate from a second horseshoe crab, Tachypleus tridentatus, can also be used to
detect endotoxin.
3.21
manufacturer
entity that designs, manufactures, fabricates, assembles, or processes a finished device
Note 1 to entry: Manufacturers include, but are not limited to, those who perform the functions of contract
sterilization, installation, relabelling, remanufacturing, repacking or specification development, and initial
distributions of foreign entities performing these functions. The term does not cover preparation of concentrates
from prepackaged dry chemicals at a dialysis facility or the handling of bulk concentrates at a dialysis facility
after responsibility for the concentrate is transferred from the manufacturer to the user.
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SIST EN ISO 11663:2016
ISO 11663:2014(E)
3.22
microbiol
...
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